- On **September 15, 2025**, aTyr Pharma, Inc. (ATYR) announced that its late-stage study of efzofitimod for treating pulmonary sarcoidosis **did not meet its main goal**.  **[1339970_82360328ed4844d98b3794d7e1b8436e_0]** 
- This failure caused aTyr's share price to **crater over 80%** on the day of the announcement.  **[1339970_82360328ed4844d98b3794d7e1b8436e_0]** 
- The company reported that the topline results **failed to meet their primary endpoint of steroid reduction** and did not achieve statistical significance.  **[1339970_82360328ed4844d98b3794d7e1b8436e_0]** 
- National shareholders rights firm Hagens Berman has initiated an investigation into whether aTyr may have **misled investors** regarding its Phase 2 efzofitimod data and Phase 3 EFZO-FIT trial design.  **[1339970_82360328ed4844d98b3794d7e1b8436e_0]**

aTyr Pharma's EFZO-FIT Trial Failure Leads to Significant Stock Drop and Investor Investigation

- aTyr Pharma presented additional findings from its Phase 3 EFZO-FIT™ study of **efzofitimod** for pulmonary sarcoidosis at the European Respiratory Society (ERS) Congress 2025 on **September 30, 2025**.  **[1339970_ea7aa8bb190d4829a17ef3df300fccb4_0]** 
- The study demonstrated significant improvements in **Fatigue Assessment Scale Total Score (p=0.0226)** and **King’s Sarcoidosis Questionnaire-General Health score (p=0.0197)** at week 48 for the **5.0 mg/kg efzofitimod treatment group** compared to placebo.  **[1339970_ea7aa8bb190d4829a17ef3df300fccb4_0]** 
- However, the study **did not meet its primary endpoint** of change from baseline in mean daily oral corticosteroid dose at week 48.  **[1339970_ea7aa8bb190d4829a17ef3df300fccb4_1]** 
- Despite missing the primary endpoint, other clinical benefits observed for the 5.0 mg/kg efzofitimod group included **KSQ-Lung score improvement (p=0.0196)** and a trend toward a greater proportion of patients achieving steroid-free status.  **[1339970_ea7aa8bb190d4829a17ef3df300fccb4_0]** **[1339970_ea7aa8bb190d4829a17ef3df300fccb4_1]**

ATYR Pharma Presents Additional Phase 3 EFZO-FIT™ Study Findings

- On **September 15, 2025**, aTyr Pharma, Inc. (ATYR) saw its share price plummet over **80%** after its late-stage study of efzofitimod for treating pulmonary sarcoidosis failed to meet its main goal.  **[1339970_20250923SF80776:0]** 
- The company announced that the topline results from its EFZO-FIT™ trial did not achieve statistical significance for the primary endpoint of steroid reduction, noting that the placebo tapering outperformed their modeling.  **[1339970_20250923SF80776:0]** 
- National shareholders rights firm Hagens Berman has initiated an investigation into whether aTyr may have misled investors regarding its Phase 2 data and the design of its Phase 3 EFZO-FIT™ trial.  **[1339970_20250923SF80776:0]** 
- Prior to the study results, aTyr had assured investors about the quality of its Phase 2 data and the multi-billion-dollar market opportunity for efzofitimod in interstitial lung disease.  **[1339970_20250923SF80776:0]**

aTyr Pharma Shares Drop Over 80% Following Failed Late-Stage Study

- On **September 15, 2025**, aTyr Pharma, Inc. shares **cratered over 80%** after its late-stage study of efzofitimod for treating pulmonary sarcoidosis did not meet its main goal.  **[1339970_20250919SF77539:0]** 
- The company announced that the EFZO-FIT™ trial's topline results failed to meet its **primary endpoint of steroid reduction** and did not achieve statistical significance.  **[1339970_20250919SF77539:0]** 
- National shareholders rights firm Hagens Berman has opened an investigation into whether aTyr may have **misled investors** about its Phase 2 data and Phase 3 EFZO-FIT™ trial design.  **[1339970_20250919SF77539:0]**

aTyr Pharma's EFZO-FIT™ Study Fails, Shares Drop Over 80%

- On **September 15, 2025**, aTyr Pharma's shares **plummeted over 80%** after its late-stage **EFZO-FITÔ trial** for **efzofitimod** in pulmonary sarcoidosis **failed to meet its primary endpoint** of steroid reduction.  **[1339970_20250917SF75656:0]** 
- The company reported that the placebo group's tapering performance **outperformed their most aggressive modeling**, resulting in a lack of statistical significance for the primary endpoint.  **[1339970_20250917SF75656:0]** 
- Shareholders rights firm Hagens Berman has initiated an investigation into whether aTyr Pharma **misled investors** regarding its Phase 2 data and Phase 3 trial design, citing prior assurances of "some of the best data" and a "multi-billion-dollar opportunity".  **[1339970_20250917SF75656:0]**

aTyr Pharma's EFZO-FITÔ Study Failure Leads to Significant Share Price Drop and Investor Scrutiny

- ATYR Pharma, Inc. announced **topline results** from its **Phase 3 EFZO-FIT™ study** of efzofitimod in **268 patients with pulmonary sarcoidosis** on **September 15, 2025**.  **[1339970_0001193125-25-202865_atyr-20250915.htm:1]** 
- The study **did not meet its primary endpoint** of change from baseline in mean daily oral corticosteroid (OCS) dose at week 48, with a reduction to an average of **2.79 mg for 5.0 mg/kg efzofitimod vs 3.52 mg for placebo (p=0.3313)**.  **[1339970_0001193125-25-202865_atyr-20250915.htm:1]** **[1339970_0001193125-25-202865_atyr-ex99_1.htm:2]** 
- Despite not meeting the primary endpoint, the study demonstrated a **clinical improvement in the King’s Sarcoidosis Questionnaire (KSQ)-Lung score** at week 48 for **5.0 mg/kg efzofitimod compared to placebo (p=0.0479)**.  **[1339970_0001193125-25-202865_atyr-20250915.htm:1]** **[1339970_0001193125-25-202865_atyr-ex99_1.htm:2]** 
- Additionally, a responder analysis showed that **29.5% of patients on 5.0 mg/kg efzofitimod achieved complete steroid withdrawal with KSQ-Lung improvement vs 14.4% in placebo (p=0.0199)**.  **[1339970_0001193125-25-202865_atyr-20250915.htm:1]** **[1339970_0001193125-25-202865_atyr-ex99_1.htm:2]** 
- The company plans to **engage with the U.S. Food and Drug Administration (FDA)** to review the results and determine the path forward for efzofitimod in pulmonary sarcoidosis, believing the findings indicate drug activity across multiple clinically relevant efficacy endpoints.  **[1339970_0001193125-25-202865_atyr-20250915.htm:1]** **[1339970_0001193125-25-202865_atyr-ex99_1.htm:2]** **[1339970_0001193125-25-202865_atyr-20250915.htm:2]**

ATYR Pharma Announces Topline Results for Phase 3 EFZO-FIT™ Study

- ATYR Pharma's Phase 3 EFZO-FIT™ study of **efzofitimod** for pulmonary sarcoidosis **did not meet its primary endpoint** of change from baseline in mean daily oral corticosteroid dose at week 48.  **[1339970_2144291_1]** 
- Despite missing the primary endpoint, the study showed that treatment with **5 mg/kg efzofitimod** resulted in **52.6%** of patients achieving complete steroid withdrawal at week 48, compared to **40.2%** on placebo.  **[1339970_2144291_1]** **[1339970_2144291_2]** 
- Patients treated with **5 mg/kg efzofitimod** also experienced a clinical improvement of **10.36 points** in the King's Sarcoidosis Questionnaire (KSQ) Lung Score, versus **6.19 points** for placebo, and the drug was **well tolerated**.  **[1339970_2144291_1]** **[1339970_2144291_3]** **[1339970_2144291_4]** 
- The primary endpoint was missed due to a **higher-than-anticipated placebo response**, with **40.2%** of placebo patients achieving complete steroid withdrawal, largely attributed to the rigorous study protocol.  **[1339970_2144291_2]** **[1339970_2144291_8]** 
- The company plans to **engage with the FDA** to determine the path forward for efzofitimod in pulmonary sarcoidosis, citing the drug's activity across multiple clinically relevant efficacy endpoints and favorable safety profile.  **[1339970_2144291_1]** **[1339970_2144291_4]**

aTYR PHARMA (ATYR)